Viewing data from:

CLODERM

NDA

CLOCORTOLONE PIVALATE | N017765 | LEGACY PHARMA INC SEZC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Bio-equivalence Vasoconstriction Activity Study for Topically Applied Clocortolone Pivalate 0.1% Cream NCT04358770	Phase 1	Completed	Sun Pharmaceutical Industries, Inc.	124	2018-03-02 → 2018-05-11

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Medicare Part D Spending

CMS annual spending data for Cloderm (2024)

Total Spending

$5K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$8.05

Spending Trend

$13K(2019)→$96K(2020)→$107K(2021)→$44K(2022)→$31K(2023)→$5K(2024)

YoY Change:-5.8%

5yr CAGR:+2.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

FARMABIOS SPACLOCORTOLONE PIVALATE (MICRONIZED)

DMF 224212009

CHEMWERTH INCCLOCORTOLONE PIVALATE

DMF 251382011

TARO PHARMACEUTICAL INDUSTRIES LTDCLOCORTOLONE PIVALATE USP, MICRONIZED

DMF 263652013

TRIFARMA SPACLOCORTOLONE PIVALATE

DMF 293382015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 16, 2003	SUPPL -24	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%

RLDAB

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.